19 Dec Social determinants of health have high impact on informed consent comprehension, study finds

By Andy Studna, Applied Clinical Trials

A recent study conducted through pediatric cancer trials found that limited health literacy and use of the Spanish language for medical communication impacted parents’ comprehension of informed consent. The authors of the study, published in JAMA Network Open, pointed to past research in this area, which showed that only 32% of parents had an understanding of the purpose behind their clinical trial, with most of the parents being non-Hispanic White individuals. This underscores the need to enhance informed consent comprehension across all populations.

The study enrolled 223 parents of children with a new cancer diagnosis at Rady Children’s Hospital San Diego in California, from October 1, 2014, to March 31, 2021.

“Linear mixed effects models were used to assess whether informed consent comprehension overall and by domain (purpose, procedures, and randomization; risks and benefits; alternatives; and voluntariness) were associated with SDOH and sociocontextual factors,” the authors wrote.

Of the 223 participants, 49.8% were Hispanic and 37.8% of this group used Spanish language for medical communications. “Use of Spanish language for medical communication was associated with lower overall IC comprehension and lower comprehension of the purpose, procedures, and randomization and voluntariness domains, highlighting the importance of language-concordant IC delivery to ensure IC comprehension,” the authors wrote.

The authors also add that among Hispanic cultural norms, respect may play a role in informed comprehension, as parents who use the Spanish language may be less willing to ask questions compared to those in the study who used the English language, according to the study. Another consideration is the tendency for clinicians to shorten and/or simplify explanations of the study to individuals who do not use the English language. Delving deeper into the study population, the authors found that unmarried marital status and older parental age were also factors that impacted comprehension. Read more …